Regulating Medical Devices in the Event of a No Deal Brexit

Last Updated on 28/01/2020 by steveperry

With Brexit negotiations and planning effecting all businesses in the UK, it is important to make sure you stay up to date with Medical Devices advice for your products. We may still be looking at a “No Deal” scenario in 2020, and are repeating the advice already given to members.

“What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal”

CONTENTS

1. Stay up to date
2. Details
3. The legislation
4. The role of the MHRA
5. Role of those manufacturing and supplying devices
6. UK Responsible Person
7. Determining whether your product is a device
8. Classification
9. Clinical investigations and performance evaluations
10. CE marking your devices and conformity assessment
11. Labelling requirements
12. Registrations
13. Post-market surveillance and vigilance
14. Contact us

For the full advice pages for the above content Click Here

Published: 26th February 2019

Source: GOV.UK

Story Link: https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario